Matthias Orth

Direct to consumer testing (DTCT) - benefit for patients?

A definition of DTCT is in vitro testing initiated and paid for by the consumer and performed either by the consumer at home, or via self-collected samples that are shipped to a nonmedical laboratory for analysis. Healthcare is subject to strict national regulations, with various laws and rules being enforced to safeguard patients. The patient can rely on (a) the healthcare provider (HCP), either alone or mostly as shared decision-making (7), will select the best diagnostic method and treatment for the patient dependent on the 4 core principals of biomedical ethics (i.e., respect for autonomy, beneficence, nonmaleficence, justice) (8) and (b) the rules of marketplace, which are the major triggers of decisions outside of healthcare, have only negligible influence on these healthcare decisions (9). HCP not complying to these core principles are heavily punished. The concept of P4-medicine (predictive, personalized, preventive, active participation of the patient) seems to have benefits to the society. The concept of P4-medicine heavily relies on technology, big data, and on social networks for public commenting by peers, and a shared decision-making between HCP and patients is heavily encouraged. However, moving responsibility from HCP to consumers may strengthen the autonomy of the consumers, but is a paradigm shift to the core principles of biomedical ethics. With DTCT, it is unclear how the patient (or consumer) is protected or empowered when regulations are lacking. DTCT are initiated by consumers without HCP consultation or guidance in test selection. The role of the laboratory specialist in this scenario is often blurred: the concept of “do no harm” by overdiagnosis can only be achieved when the laboratory specialist can intervene before testing has been performed DTCT remains largely unregulated, operating in a legal gray area, with most tests lacking claims of medical benefit. There is a significant risk of substantial psychological, medical, and economical damage if DTCT data are used for medical decisions (in particular by follow-up procedures), as well as a wider negative impact on society, particularly concerning the ineffective allocation of medical resources. Data integrity issues in DTCT remain unresolved, and HCP face considerable personal liability risks when relying on DTCT data. Any long- term storage of such electronic data must ensure a clear separation between DTCT data and conventional legitimate medical records. Consumer empowerment can only be achieved when health literacy is improved and ordering of DTCT is performed only when the consumer was able to make an informed decision. The information given during the DTCT ordering process should be structured and information about the validity of the test should not contain unproven claims. All endeavors to improve health literacy should be based on evidence and carried out by health policymakers, schools, patient organizations, and relevant medical experts, including specialists in laboratory medicine. To avoid overuse of the health system by overmedicalization, offers of DTCT laboratories must be compliant with the core principles of bioethics.